California's Slow Pace on Stem Cell Snake Oil: State Medical Regulators May Take First Stab This Summer

California regulation of an industry that sells dubious and risky "stem cell" treatments now appears to be solely in the hands of the state Medical Board, which has been mulling the matter for at least 11 months.

Both nationally and in California, the number of unregulated clinics has risen sharply with estimates of more than 1,000 nationwide, with the largest number in California. 

Jonathan Thomas, chairman of the $3 billion state stem cell agency, has described the fast-growing clinics as snake-oil enterprises.

The clinics peddle what they call stem cell treatments to desperate patients. The treatments cost thousands of dollars. Some patients have reported losing their vision as a result. Last December, the federal government reported that 12 persons were hospitalized because of infections from treatment by a California clinic. Some of the material involved was contaminated with fecal bacteria.

The New York Times reported this week that across the nation the clinics have "attracted huge numbers of patients, who pay thousands of dollars for unproven, risky procedures." The Times piece echoed a bleak national picture that was painted earlier by the Washington Post. 

A spokesman for the California Medical Board, Carlos Villatoro, said this week that a task force of the board is expected to hold its first meeting this summer to deal with stem cell clinics. "The task force should be meeting soon and potentially holding an interested parties meeting, hopefully before the next board meeting," he said in an email to the California Stem Cell Report.

The next board meeting comes in August. The task force consists of two members of the state board:

Randy Hawkins, LA Sentinel photo

Randy Hawkins of Los Angeles, who is a clinical assistant professor of medicine at the Charles Drew University of Medicine and Science in Los Angeles, and Howard Krauss of Santa Monica, Ca., who is a clinical professor of ophthalmology and

Howard Krauss, PNI photo

neurosurgery at the John Wayne Cancer Institute at Providence Saint John’s Health Center in Santa Monica. 

State legislation to deal with the burgeoning problem is moribund and may or may not be resurrected.

Art Torres, vice chairman of the board of the California stem cell agency, has been working on the measure (AB617). He served for 22 years in the state legislature and is a former head of the California Democratic Party. 

Last month, Torres described the stem cell clinic measure as "dead." He said the reasons for its demise are "unclear," along with the failure of another bill dealing with sickle cell disease. Torres told the board, 

"They haven't told us why they opposed it, and even the author of the bills can't figure out why their bills remained in what's called the suspense file of the Assembly Appropriations Committee."

Torres later told the California Stem Cell Report that it was possible that the content of the bill could be amended into another measure that is farther along in the legislative process. But he said that no clear pathway to final passage was evident. 

In New York, the state attorney general has charged one stem cell clinic with fraud. In California, Attorney General Xavier Becerra has remained mum on the subject. 

Captain Kirk, Snake Oil and Stem Cell Treatments

It's time for stem cell whack-a-mole.

That's the game where regulators -- coming in late -- try to prevent snake-oil clinics from harming desperate patients with purported stem cell treatments and ripping off them for thousands of dollars.  

More than 1,000 dubious clinics are estimated to exist across the country with the largest number in California, which is lagging in its regulatory efforts.  More spring up every day with even Captain Kirk of Star Trek weighing in on the alleged benefits of the unregulated procedures.

William Wan of the Washington Post captured the national scene in an article late on Friday. He said don't get too excited about a favorable court decision involving one operation in Florida, which claims to turn body fat into beneficial stem cells.

Wan wrote,

"(T)he company said it would follow the federal judge’s ruling and stop selling the fat-based procedure. But it quickly followed up with a clarification: It would continue offering stem cell treatments, but instead of fat, rely on patients’ bone marrow and other tissues to harvest the cells it claims can cure conditions as varied as spinal cord injuries and erectile dysfunction.

"'It’s a bit like playing whack-a-mole,' said Peter Marks, FDA’s top official for biologic products."

The situation has been building for long time. Wan wrote,

“After years of largely ignoring the issue, the FDA is finally making more of an effort, but it’s not as if this marketplace is melting away,” said Leigh Turner, a bioethicist at the University of Minnesota. 

"Because no one had documented exactly how many stem cell clinics existed, Turner — working with collaborators (UC Davis researcher Paul Knoepfler) — began tracking them in a database several years ago. In 2009, there appeared to be only two in the United States; by 2017, there were at least 700. Turner believes there are currently more than 1,000."

"Turner compared the for-profit stem cell industry to a balloon. As the FDA and consumer advocates squeeze one end, other parts of the enterprise expand. 'For every one that’s disappeared, we’re finding seven more that are popping up.'"

Wan noted another effort in California that could affect a number of clinics. 

"Meanwhile, the government is pushing forward in a second federal court lawsuit against another stem cell business in California. That lawsuit has the potential to halt the fat-based stem cell treatment in multiple clinics because the government filed it against a company called Cell Surgical Network, which serves as an umbrella for dozens of affiliated clinics around the country."

An attempt to step up state regulation in California, however, has ground to a halt. Legislation (AB617) by Assemblyman Kevin Mullin, D-San Mateo, is now not even on life support. It is buried in the Assembly Appropriations Committee. Its content could surface in another measure that still has some technical life in the Capitol, but the outlook is more than dim. 

The scene is not much brighter with California's medical board. Last year said it would look into the dubious clinics. In April, it said hearings might begin no later than early this month. Nonetheless, a check of the agency's web site this weekend did not turn up any notice of such a meeting.

California's Intial Moves on Regulation of Dubious, Unregulated Stem Cell Clinics

Legislation targeting unregulated,"snake-oil," stem cell clinics easily cleared its first hurdle yesterday and was put on track for speedy approval by the  California legislature.

The measure was amended by its author, Assemblyman Kevin Mullin, D-San Mateo, to set deadlines for moving forward next year with new regulation of the clinics, which have proliferated in California and elsewhere.

The proposal is supported by the state's $3 billion stem cell agency. Jonathan Thomas, chairman of the agency, has called the treatments "snake oil."

The clinics peddle ostensible stem cell therapies for which they charge thousands of dollars. The treatments are not approved by the federal Food and Drug Administration. Some have resulted in injury, including blindness.

An analysis of the measure (AB617) by legislative staff said,

"According to the Centers for Disease Control and Prevention in the past year, at least 17 individuals across five states were hospitalized after being injected with therapeutic products made from umbilical cord blood. These particular illnesses have been identified as bacterial infections that have caused swollen spinal disc, infected bones and joints, and abscesses on their backs. Of the 17 infections, 15 have been linked to a single California based company that sells vials of a solution containing umbilical cord blood that they market to ‘stimulate regenerative healing.'" 

Mullin's  bill would charge the state Department of Public Health with creating a body by February 2020 that could enact "emergency" regulations, with 90-day  notice, to deal with clinics not in compliance with federal regulations. The panel would also be charged with making recommendations to the legislature by July of next year for new laws concerning the clinics.

The 2020 deadlines were added to the bill on Monday. However, it is unlikely to mean creation of emergency regulations any sooner than the middle of next year, given state's normal processes.

Mullin's bill won unanimous approval yesterday and was sent to the Assembly Appropriations Committee and was recommended for the consent calendar, which means that it will receive routine approval unless other issues come up. The bill also requires full Assembly and Senate approval and a signature from the governor.